Introducer assembly with cap and method of using same

ABSTRACT

An introducer sheath assembly (10) having a sheath tube (12), a hub (16), a valve (30) and a valve-retaining cap (50) on the proximal end of the hub. The cap (50) is so secured to the hub (16) as to have a closed, locked position and also an open position permitting access to the interior of the hub and the valve (30) while the cap (50) remains secured to the hub (16).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application of U.S. patentapplication Ser. No. 15/071,289, filed Mar. 16, 2016 which is acontinuation application of U.S. patent application Ser. No. 12/332,025(now U.S. Pat. No. 9,352,129) filed Dec. 10, 2008, and issued May 31,2016, which claims the benefit of U.S. provisional patent applicationSer. No. 61/007,613 filed Dec. 13, 2007, the contents of which areincorporated herein by reference.

FIELD OF THE INVENTION

This relates to the field of medical devices, and more particularly tocatheter introducer sheath assemblies.

BACKGROUND OF THE INVENTION

Catheters are often used for the delivery and withdrawal of fluids toand from a blood vessel in a patient, respectively. The fluids may bemedication that is administered to the patient, or blood that iswithdrawn from the patient. The catheter may also be used forhemodialysis, in which blood is withdrawn from the patient, purified andreturned simultaneously through respective lumens of the catheter, andmuch of the catheter remains within the patient's vasculature for anextended period of time for repeated treatments.

Typically, to insert a catheter into a blood vessel, the blood vessel islocated by known methods. An aspirating needle is inserted into thevessel to confirm placement within the vessel. A guide wire is theninserted through a proximal end of the aspirating needle and into thevessel. The aspirating needle is withdrawn by sliding the needleproximally over the guide wire, leaving the guide wire within thevessel. If a catheter with a sufficiently hard wall is being used, thecatheter may be slid over the guide wire, directly into the vessel.

However, for some catheters, particularly soft walled catheters, adilator is required to dilate the vessel at the insertion point in orderto accommodate the insertion of the catheter. The dilator is typicallyinserted into a sheath and initially used as a dilator and sheathassembly. The assembly is inserted into the vessel over the guide wireand the dilator is used to dilate the insertion opening in the vesselwall. After the insertion opening is dilated, the dilator and the guidewire are removed from the vessel by removing both the dilator and theguide wire proximally from the sheath. The sheath remains in the vesselto accommodate insertion of the catheter through the sheath and into theblood vessel.

Conventional assemblies provide one-way valves within the introducer hubfor hemostasis, that is, preventing blood flow from the patient'svasculature from the incision made for eventual catheter insertion; thevalve seals the passageway while permitting insertion therethrough by aguidewire and a dilator and a catheter. Commonly, proximal caps areaffixed to the proximal end of the introducer hub to retain the valvetherewithin.

It commonly happens that blockages occur within introducer assembliesdue to clotting of blood egressing the vascular incision formed forinsertion of the catheter into the vasculature. Upon such an occasion,the introducer must be removed and replaced by another, a procedure thatgreatly extends the time needed and complicating the procedures followedby the practitioner to implant the catheter, thereby exposing thepatient to greater risk of infection due to bleeding from the incision.

It is desired to provide an introducer assembly facilitating access bythe practitioner to the passageway within the introducer hub to clear ablockage that may occur within the introducer.

BRIEF SUMMARY OF THE INVENTION

Briefly, the present invention provides an introducer assembly having asheath, a hub, a valve disposed transverse to the passageway extendingbetween the proximal and distal ends of the sheath and hub, and a capfor retaining the valve in proper position within the hub. The cap isattached to the hub at one side thereof by a pivot arrangement wherebythe cap can be rotated by the practitioner between a closed position andan open position all while remaining secured to the assembly. A latch onthe opposite side of the cap from the pivot arrangement latchinglysecures to a catch on the opposite side of the hub from the pivotarrangement to secure the cap in its closed position. When the cap is inthe open position, the valve is removable by the practitioner permittingaccess to the introducer's passageway for clearance of a blockagewhereafter the valve or a replacement valve, if necessary, can bereinserted into position in the hub and the cap can be returned to itsclosed position, eliminating the necessity of removing the entireintroducer assembly from the patient and replacing it with another.

The method of the present invention includes the steps of placing anintroducer assembly in position accessing the vasculature of the patientand having a passageway extending therethrough between a distal end anda proximal end, the assembly including a valve-retention cap movablyaffixed to the assembly's proximal end between a closed positionretaining the valve therein and an open position permitting access tothe introducer passageway, moving the proximal cap to the open position,removing the blockage, and moving the cap to its closed position.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate the presently preferredembodiments of the invention, and, together with the general descriptiongiven above and the detailed description given below, serve to explainthe features of the invention. In the drawings:

FIG. 1 is an isometric view of an introducer sheath with dilatorinserted therethrough and also showing an extension tube extending froma side port of the introducer hub;

FIG. 2 is an isometric distal end view of the assembly of FIG. 1;

FIG. 3 is an enlarged isometric view of the proximal end of the assemblyof FIG. 1 with the components shown exploded from the introducersheath's elongate tube;

FIGS. 4 and 5 are elevation and exploded elevation views, respectively,of the hub assembly of the introducer sheath of FIGS. 1 to 3, showingthe introducer hub, the extension tube and the cap of the presentinvention; and

FIGS. 6 and 7 are, respectively, an exploded isometric view of theproximal end, and an isometric view of the proximal introducer sheathend with the cap attached to the introducer hub and rotated to an openposition with the valve exploded outwardly from the hub, exposing thepassageway.

DETAILED DESCRIPTION OF THE INVENTION

In the drawings, like numerals indicate like elements throughout.Certain terminology is used herein for convenience only and is not to betaken as a limitation on the present invention. The terms “distal” and“proximal” refer, respectively, to directions closer to and away fromthe insertion tip of a catheter in an implantable catheter assembly. Theterminology includes the words specifically mentioned, derivativesthereof and words of similar import. The embodiments illustrated beloware not intended to be exhaustive or to limit the invention to theprecise form disclosed. These embodiments are chosen and described tobest explain the principle of the invention and its application andpractical use and to enable others skilled in the art to best utilizethe invention.

Introducer assembly 10 is seen in FIGS. 1 and 2, and includes anelongate tubular sheath 12 extending to a distal end 14, an introducerhub 16 affixed to a proximal end of the sheath 12 and having a side port18 from which extends an extension tube 20 with luer fitting 22, and astrain relief 24 at a distal end of the sheath hub 16 and around thetubular sheath 12. A dilator 40 includes an elongate dilator shaft 42extending from a distal tip 44 to a proximal end onto which is affixed adilator hub 46; the dilator's distal tip 44 protrudes beyond the distalend 14 of the tubular introducer sheath 12 when the dilator is fullyinserted into and through the introducer assembly 10.

With reference to FIG. 3, hub 16 defines therethrough a passageway 26extending to the passageway of the sheath 12. Recessed into the proximalend of the hub 16 is a valve seat 28 into which is placed a valve 30that preferably includes a slit 32 (see FIG. 7) at the valve centerenabling insertion therethrough of dilator shaft 42 and eventually acatheter (not shown). Also, the proximal end of the hub includes on oneside a cap capture tab 34 projecting proximally that includes pivot pins36 projecting laterally from both sides thereof. On the opposite side ofthe hub proximal end is a catch 38 to which the cap will latch in itsclosed position.

Cap 50 includes a recess 52 along its distal surface defining a valveseat (see FIGS. 5 and 7), and when cap 50 is attached to the hub 16 andin its closed position, retains valve 30 compressed in position withinthe valve seat 28,52. Referring to FIGS. 3 to 7, cap 50 is seen to havea lift tab 54 depending from one side thereof that will extend alongsidethe hub when cap 50 is in position but project somewhat outwardlyenabling manual grasping thereof to rotate cap 50 to an open position,as shown in FIG. 7. Cap 50 will pivot as a result of cooperating tabs 56on the opposite cap side from lift tab 54, which tabs includes holes 58therethrough associated with pivot pins 36 of cap capture tab 34 of hub16. A latch ledge 60 is defined on the inner surface of lift tab 54 thatlatches to catch 38 of hub 16, to secure cap 50 in its closed position.Proximal aperture 62 of cap 50 permits insertion thereinto of dilatorshaft 42 and eventually the catheter (not shown); additionally proximalaperture 62 may includes threads or other features that cooperate with acomplementary locking section of the dilator hub 46 to releasably lockthe dilator to the introducer sheath assembly.

with the present invention, the cap remains secured to the hub not onlyin the closed position but also in its open position and is thus not aloose piece, if the practitioner must obtain access to the introducersheath passageway to remove a blockage such as a clot.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention as defined by the appended claims.

What is claimed is:
 1. An introducer assembly comprising: an introducersheath tube, a hub at a proximal end of the sheath tube and having a hubpassageway aligned with a sheath tube passageway of the sheath tube, avalve sealing the hub passageway; the valve being capable of permittinginsertion therethrough of a medical device, and a valve-retaining cap,wherein the cap is disposed at a hub proximal end of the hub; the cap isconfigured to move between a closed position and an open positionpermitting access to the valve and the hub passageway; and wherein thehub proximal end and a cap distal end of the cap each define recessescomprising valve seats that compress the valve into a retained positionwithin the assembly when the cap is in the closed position.
 2. Theintroducer assembly of claim 1, wherein the cap capture section is onetab having pivot pins projecting laterally from both sides thereof, andthe cooperating capture section of the cap is two tabs that arepositionable to respective sides of the one tab and define pivot holesinto which are received the pivot pins of the one tab.
 3. The introducerassembly of claim 1, wherein the hub includes a catch and the capincludes a latch cooperable with the catch to lock the cap in a latchedclosed position and an unlatched open position.
 4. The introducerassembly of claim 3, wherein the cap includes a lift tab having aninside surface facing the hub when the cap is in the latched closedposition and the latch is defined along the inside surface of the lifttab, and the lift tab facilitating manual grasping thereof to unlatchthe cap to move the cap to the unlatched open position.
 5. Theintroducer assembly of claim 1, wherein the hub proximal end and a capdistal end of the cap each define recesses comprising valve seats thatcompress the valve into a retained position within the assembly when thecap is in the closed position.
 6. The introducer assembly of claim 1,wherein the hub includes a catch on an opposite side from the capcapture section and the cap includes a latch cooperable with the catchto lock the cap in a latched closed position.
 7. The introducer assemblyof claim 6, wherein the cap includes a lift tab having an inside surfacefacing the hub when the cap is in the latched closed position and thelatch is defined along the inside surface of the lift tab, and the lifttab facilitating manual grasping thereof to unlatch the cap to move thecap to an unlatched open position.
 8. The introducer assembly of claim6, wherein the hub proximal end and a distal end of the cap each definerecesses respectively thereinto comprising cooperating valve seats thatcompress the valve into a retained position within the assembly when thecap is in the latched closed position.
 9. An introducer assemblycomprising: an introducer sheath tube, a hub at a proximal end of thesheath tube and having a passageway aligned with a sheath tubepassageway of the sheath tube, a valve sealing the hub passageway; thevalve being capable of permitting insertion therethrough of a medicaldevice, and a valve-retaining cap, wherein the cap is disposed at a hubproximal end of the hub; the cap is configured to move between a closedposition and an open position permitting access to the valve and the hubpassageway; and wherein the hub includes at a proximal end thereof a capcapture section and the cap includes a cooperating capture section thatsecures the cap to the hub while permitting the cap to be moved betweenthe closed position and the open position with respect to the hub, andwherein the hub includes a catch on an opposite side from the capcapture section and the cap includes a latch cooperable with the catchto lock the cap in a latched closed position.
 10. The introducerassembly of claim 9, wherein the cap capture section is one tab havingpivot pins projecting laterally from both sides thereof, and thecooperating capture section of the cap is two tabs that are positionableto respective sides of the one tab and define pivot holes into which arereceived the pivot pins of the one tab.
 11. The introducer assembly ofclaim 9, wherein the hub includes a catch and the cap includes a latchcooperable with the catch to lock the cap in a latched closed positionand an unlatched open position.
 12. The introducer assembly of claim 11,wherein the cap includes a lift tab having an inside surface facing thehub when the cap is in the latched closed position and the latch isdefined along the inside surface of the lift tab, and the lift tabfacilitating manual grasping thereof to unlatch the cap to move the capto the unlatched open position.
 13. The introducer assembly of claim 9,wherein the hub proximal end and a cap distal end of the cap each definerecesses comprising valve seats that compress the valve into a retainedposition within the assembly when the cap is in the closed position. 14.The introducer assembly of claim 9, wherein the hub includes a catch onan opposite side from the cap capture section and the cap includes alatch cooperable with the catch to lock the cap in a latched closedposition.
 15. The introducer assembly of claim 14, wherein the capincludes a lift tab having an inside surface facing the hub when the capis in the latched closed position and the latch is defined along theinside surface of the lift tab, and the lift tab facilitating manualgrasping thereof to unlatch the cap to move the cap to an unlatched openposition.
 16. The introducer assembly of claim 14, wherein the hubproximal end and a distal end of the cap each define recessesrespectively thereinto comprising cooperating valve seats that compressthe valve into a retained position within the assembly when the cap isin the latched closed position.